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India to Ban 300 combination Drugs Including Some Cough Syrups of Abbott, Pfizer

India has banned 94 drugs and their use in combination already while more than 300 will be banned this week, said K.L. Sharma of the Union Health Ministry after a committee reviewed more than 6,000 combination drugs in the market being sold without approval.

Image courtesty: www.anh-usa.org

The list of combination drugs include popular the codeine-based cough syrups Phensedyl and Corex made by Abbott and Pfizer. Phensedyl drug alone reportedly contributed $300 million to Abbott’s revenue from India, which has become a dumping ground where half the drugs sold in 2014 were clasfied “fixed dose combinations.”

Though combination drugs are not banned per se, failure to adhere to ratios in drug mix has led to mushrooming of combination drugs in the country, especially by some Chennai and Hyderabad-based medicines’ manufacturers.

The committee reviewed 6,000 combinations in the market based on state government authorities’ approval and asked the pharmaceutical companies to prove their safety and efficacy. After classifying the drugs into rational, irrational, and those require further study, the committee has recommended more than 300 drugs which will be prohibited, Sharma told Reuters.

While World Health Organization is warning against the increased use of antibiotic combinations due to increased resistence, India is facing an overwhelming market for combination drugs than generic drugs, not seen in other markets. Several reports in the past have highlighted how certain combination drugs are hitting the market without approval, while they are not allowed in the United States, Europe, Japan or Australia.

To see the list of 94 drugs and their combinations which have been banned already, click here:





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